The vision system operator¿s manual contains instructions for proper prime and setup.The graphical user interface also prompts the user through all of the steps required to prime and tune the phaco handpiece appropriately.The operators manual also states the following warning(s): adjusting aspiration rates or vacuum limits above the preset values, or lowering the iop or iv pole below the preset values, may cause chamber shallowing or collapse which may result in patient injury.Ensure that appropriate system parameters and system settings are selected prior to starting the procedure.Parameter and system settings include, but are not limited to, ultrasound mode, ultrasound power, vacuum, aspiration flow rate, bottle height, iop, etc.If stream of fluid is weak or absent while filling test chamber, good fluidics response will be jeopardized.Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye.Ensure that the tubings are not occluded during any phase of operation.If the handpiece test chamber is collapsed after tuning, there is a potential of low irrigation flow through the handpiece and may result in a fluidic imbalance.This, in turn, may cause a shallowing or collapsing of the anterior chamber.Good clinical practice dictates testing for adequate irrigation, aspiration flow, reflux, and operation as applicable for each handpiece prior to entering eye.There is no evidence that the design or manufacturing of the handpiece contributed to the reported event.The handpiece serial number (s/n) was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.With the information obtained, the customer reported event was unable to be confirmed.The system serial number (s/n) was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.With no additional, related information provided, the customer reported event could not be confirmed.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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